# US 11,298,225 B2 · Medical implant with seamlessly connected bacterial cellulose

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- Number: US 11,298,225 B2
- Document ID: US11298225B2
- Status: Granted
- Kind: B2
- Application number: 16/387,724
- Filed: 2019-04-18
- Published: 2019-11-28
- Granted: 2022-04-12
- Earliest claimed: 2018-05-23
- Assignees: BIOTRONIK SE & Co. KG
- Applicants: Biotronik AG
- Inventors: Alexander Rzany; Tina Pieger; Bernhard Hensel
- Web page: https://patentgrep.com/patent/US11298225B2

## CPC

- A61F 2/2415: {Manufacturing methods}
- A61F 2/06: Blood vessels
- A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)}
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2/2463: {Implants forming part of the valve leaflets}
- A61L 31/042: {Polysaccharides}
- A61L 31/14: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61F 2/2475: {Venous valves}
- A61F 2002/072: {Encapsulated stents, e.g. wire or whole stent embedded in lining}
- A61L 27/507: {for artificial blood vessels (apparatus for applying cells on a blood vessel prosthesis A61F2/062)}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

An implant has a support structure (e.g., alloplastic) such as a stent or a scaffold, and a functional element (e.g., a heart valve) including or made of bacterial cellulose. At least a part of the support structure is embedded in the functional element or in an extension thereof so as to connect the functional element to the structural element via positive fit.

## Claims

### Claim 1

An implant with a support structure and a functional element produced by a method comprising the following steps:
a) providing the support structure, the support structure having a three-dimensional shape;
b) providing a three-dimensional mold of the functional element;
c) positioning the mold relative to the support structure;
d) providing a medium comprising a bacterial cellulose-producing bacteria such that the medium contacts the mold and the support structure;
e) subjecting the mold, the support structure, and the medium to bacterial cellulose-growing conditions to grow bacterial cellulose on, in, or on and in the mold (1) to form the functional element from the bacterial cellulose and (2) to embed at least a part of the support structure in at least a part of the bacterial cellulose of the functional element, thereby connecting the functional element to the support structure; and
f) drying the bacterial cellulose at a temperature of from 40 to 70° C.,
thereby forming the functional element comprised of non-swellable bacterial cellulose and having a three-dimensional shape that deviates at least in part from the three-dimensional shape of the support structure, wherein at least a part of the support structure is embedded in the functional element.

### Claim 2 (depends on 1)

The implant according to claim 1, which further comprises a step of exposing the bacterial cellulose to at least one structure-stabilizing solution before step f).

### Claim 3 (depends on 1)

The implant according to claim 1, further comprising a step of removing the mold after step e) and further growing the bacterial cellulose on the functional element, on at least a part of the support structure, or on the functional element and at least part of the support structure, in an absence of the mold.

### Claim 4 (depends on 1)

The implant according to claim 1, which comprises growing the bacterial cellulose in step e) by incubating the support structure and a side of the mold facing the support structure in the medium comprising bacterial cellulose-producing bacteria.

### Claim 5 (depends on 4)

The implant according to claim 4, wherein the cellulose-producing bacteria is Acetobacter xylinum.

### Claim 6 (depends on 1)

The implant of claim 1 wherein after step e) the bacterial cellulose is washed.

### Claim 7 (depends on 1)

The implant of claim 1 wherein in step f) the bacterial cellulose is dried at a temperature of 60° C.

### Claim 8 (depends on 1)

The implant of claim 1, wherein the functional element formed in step e) has a thickness of 0.5 to 10 mm.

### Claim 9 (depends on 8)

The implant of claim 8, wherein the functional element formed in step e) has a thickness of 2 to 4 mm.